Back to resultsSub-Sensitivity to Long-Acting Bronchodilators (LABA)
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
fluticasone propionate and salmeterol
budesonide and formoterol
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
Eligibility Criteria
Inclusion Criteria:
- 20 subjects males or females 18-65 years of age with physician diagnosed asthma Diagnosis of asthma > 12 months Currently on 2 puffs SABA bid. Baseline percent FEV1 of greater than 60% and less than or equal to 100% 12% reversibility in the previous 12 months 12% reversibility at Screening Visit Positive MTC (≤ 8mg/ml) at the end of 2 week Run-In Currently symptomatic with ACT score less than 19 at the end of run in on ICS ≥ 200 and ≤ 400 ug/day Non-smoker or ex-smoker with < 10 pk year who stopped > 1 year ago
Exclusion Criteria:
- Asthma exacerbation, significant airflow obstruction, or respiratory infection between Visits 0 and 2. Patients who fail screening because of one of these events may be re-screened once (at least 4 weeks after recovery from the event).
Pre-existing lung disease other than asthma, including active infections Clinically significant medical disease that is uncontrolled despite treatment or is likely in the opinion of the investigator to require a change in therapy during the study Noncompliance or inability to participate in all assessments. Current smoker or former smoker with a lifetime smoking history of ≥ 10 pack-years. A current smoker is defined as someone who has smoked one or more cigarettes per day (or marijuana or a pipe or cigar) for >/= 30 days within the 24 months prior to Visit 1.
Any individual who smokes (cigarettes, marijuana, pipe, or cigar) occasionally, even if for < 30 days in the 24 months Prior to Visit 1, must agree to abstain from all smoking from the time of consent through completion.
History of substance abuse that may impair or risk the patient's full participation in the study, in the judgment of the investigator.
Participation in another interventional clinical trial (including a trial of an approved drug or an interventional study that does not include medication) within 30 days or 5 half-lives of the investigational agent, whichever is longer.
Women with a positive urine pregnancy test.
Sites / Locations
- National Jewish Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
fluticasone propionate and salmeterol
budesonide and formoterol
Arm Description
Outcomes
Primary Outcome Measures
Improvement in PC20
Improvements in PC20 as measured by methacholine challenge between the two treatment groups at the end of the first 4 week period to determine efficacy between low dose Advair and Symbicort.
Secondary Outcome Measures
Changes in FEV1
Changes in peak pre-bronchodilator FEV1 [measured at hours 10, 11, 12 post evening dose] over the four week treatment periods and over each 12 hour dosing period (pre evening dose FEV1).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01117116
Brief Title
Sub-Sensitivity to Long-Acting Bronchodilators (LABA)
Official Title
Sub-Sensitivity to Long-Acting Bronchodilators (LABA)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Jewish Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to look at whether Advair® and SYMBICORT® have different effects on airway constriction by means of methacholine challenge testing.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
fluticasone propionate and salmeterol
Arm Type
Active Comparator
Arm Title
budesonide and formoterol
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
fluticasone propionate and salmeterol
Other Intervention Name(s)
Advair
Intervention Description
45/4.5 two puffs twice daily
Intervention Type
Drug
Intervention Name(s)
budesonide and formoterol
Other Intervention Name(s)
Symbicort
Intervention Description
80/4.5 two puffs twice daily
Primary Outcome Measure Information:
Title
Improvement in PC20
Description
Improvements in PC20 as measured by methacholine challenge between the two treatment groups at the end of the first 4 week period to determine efficacy between low dose Advair and Symbicort.
Time Frame
Study Completion
Secondary Outcome Measure Information:
Title
Changes in FEV1
Description
Changes in peak pre-bronchodilator FEV1 [measured at hours 10, 11, 12 post evening dose] over the four week treatment periods and over each 12 hour dosing period (pre evening dose FEV1).
Time Frame
Study Completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
20 subjects males or females 18-65 years of age with physician diagnosed asthma Diagnosis of asthma > 12 months Currently on 2 puffs SABA bid. Baseline percent FEV1 of greater than 60% and less than or equal to 100% 12% reversibility in the previous 12 months 12% reversibility at Screening Visit Positive MTC (≤ 8mg/ml) at the end of 2 week Run-In Currently symptomatic with ACT score less than 19 at the end of run in on ICS ≥ 200 and ≤ 400 ug/day Non-smoker or ex-smoker with < 10 pk year who stopped > 1 year ago
Exclusion Criteria:
Asthma exacerbation, significant airflow obstruction, or respiratory infection between Visits 0 and 2. Patients who fail screening because of one of these events may be re-screened once (at least 4 weeks after recovery from the event).
Pre-existing lung disease other than asthma, including active infections Clinically significant medical disease that is uncontrolled despite treatment or is likely in the opinion of the investigator to require a change in therapy during the study Noncompliance or inability to participate in all assessments. Current smoker or former smoker with a lifetime smoking history of ≥ 10 pack-years. A current smoker is defined as someone who has smoked one or more cigarettes per day (or marijuana or a pipe or cigar) for >/= 30 days within the 24 months prior to Visit 1.
Any individual who smokes (cigarettes, marijuana, pipe, or cigar) occasionally, even if for < 30 days in the 24 months Prior to Visit 1, must agree to abstain from all smoking from the time of consent through completion.
History of substance abuse that may impair or risk the patient's full participation in the study, in the judgment of the investigator.
Participation in another interventional clinical trial (including a trial of an approved drug or an interventional study that does not include medication) within 30 days or 5 half-lives of the investigational agent, whichever is longer.
Women with a positive urine pregnancy test.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rohit K Katial, M.D.
Organizational Affiliation
National Jewish Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Sub-Sensitivity to Long-Acting Bronchodilators (LABA)
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